Comparative Effects of Aspirin, Metformin and SGLT2 Inhibitors on Liver Enzymes, Lipid Profile, and FibroScan Findings in Non-Alcoholic Fatty Liver Disease (AS-NAFLD)
Comparison Between the Effect of Aspirin, Metformin, and SGLT2 Inhibitor Intake in Non-Alcoholic Fatty Liver on Liver Enzymes, Lipid Profile, and the Results of FibroScan
Non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD), is a common hepatic manifestation of metabolic dysfunction and may progress from simple steatosis to steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.
This randomized clinical trial evaluated and compared three pharmacological approaches with different mechanisms of action: low-dose aspirin as an anti-inflammatory and antiplatelet therapy, dapagliflozin as a sodium-glucose cotransporter-2 (SGLT2) inhibitor with metabolic effects, and metformin as an insulin-sensitizing therapy.
The study assessed their effects on liver enzymes, lipid profile, and FibroScan-derived measures of hepatic steatosis and liver stiffness over a 6-month treatment period.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This was a single-center, open-label, parallel-group randomized controlled clinical trial conducted over 6 months in adults diagnosed with non-alcoholic fatty liver disease (NAFLD), currently referred to as metabolic dysfunction-associated steatotic liver disease (MASLD).
Participants were randomly allocated to one of three treatment groups:
- Aspirin group: aspirin 100 mg orally once daily for 6 months.
- Dapagliflozin group: dapagliflozin 10 mg orally once daily for 6 months.
- Metformin group: metformin 1000 mg orally once daily for 6 months.
The study was designed to compare the hepatic and metabolic effects of anti-inflammatory/antiplatelet therapy, SGLT2 inhibition, and insulin-sensitizing therapy in patients with NAFLD/MASLD.
Participants underwent clinical and laboratory assessment at baseline and after 6 months of treatment. Laboratory assessments included liver enzymes, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP), together with lipid-profile parameters, including total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C).
Hepatic steatosis and liver stiffness were assessed noninvasively using vibration-controlled transient elastography (FibroScan). The controlled attenuation parameter (CAP, dB/m) was used to assess hepatic steatosis, while liver stiffness measurement (LSM, kPa) was used to assess liver stiffness/fibrosis-related changes.
The main study outcomes included changes from baseline to 6 months in FibroScan-derived CAP and LSM values, liver enzymes, and lipid-profile parameters. Additional metabolic and clinical outcomes included body weight, waist circumference, and other relevant metabolic indicators where available.
Statistical Analysis: Continuous variables were summarized using appropriate descriptive statistics. Within-group changes from baseline to 6 months were evaluated using paired statistical tests as appropriate. Comparisons among the three treatment groups were performed using analysis of variance (ANOVA) or corresponding non-parametric tests, as applicable. Analysis of covariance (ANCOVA) adjusting for baseline values was used when baseline differences were present. Appropriate post-hoc pairwise comparisons were performed where required. All statistical tests were two-sided, and a p-value <0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beni Suweif Governorate
-
Banī Suwayf, Beni Suweif Governorate, Egypt, 0000
- Faculty of Pharmacy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria: if one or more the following are present:
- Diabetes mellitus, unless receiving only Dapagliflozin for treatment.
- Adult individuals (18-65 years) with a clinical diagnosis of NAFLD based on liver ultrasound
- No history of alcohol consumption or consumption within 3 months.
- Absence of other liver diseases.
- No significant renal or gastrointestinal issues that could interfere with treatment.
Exclusion Criteria:Patients were excluded from our study if one or more the -following are present:
- Pregnancy or breastfeeding.
- Active chronic viral hepatitis or autoimmune liver disease.
- History of gastrointestinal bleeding or other contraindications for Aspirin.
- Severe renal insufficiency.
- Alcohol intake
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: aspirin group
Participants were received 100 mg of aspirin as oral daily doses for 6 months.
|
Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months.
Other Names:
|
|
Experimental: Dapagliflozin group
Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months.
|
Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months.
Other Names:
|
|
Experimental: Metformin group
Participants received metformin 1000 mg orally once daily for 6 months.
|
Participants received metformin 1000 mg orally once daily for 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lipid profile and Fibroscan results
Time Frame: 6 months
|
|
6 months
|
|
lipid profile and Fibroscan evalution
Time Frame: 6 months
|
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
indicators of metabolic improvement
Time Frame: 6 months
|
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Metabolic Diseases
- Digestive System Diseases
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Liver Diseases
- Fatty Liver
- Nutritional and Metabolic Diseases
- Diabetes Mellitus, Type 2
- Non-alcoholic Fatty Liver Disease
- Organic Chemicals
- Pharmaceutical Preparations
- Dosage Forms
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Phenols
- Benzene Derivatives
- Biguanides
- Guanidines
- Amidines
- Salicylates
- Hydroxybenzoates
- Aspirin
- Metformin
- Tablets
- dapagliflozin
Other Study ID Numbers
- Galala U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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